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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K931073
Device Name CATH-FINDER
Applicant
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
PHARMACIA DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/02/1993
Decision Date 05/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
Recalls CDRH Recalls
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